In re Breast Implant Cases, 92 CV 7821 (S.D.N.Y.)

• Decision Date: 23 October 1996
• Docket Number: 92 CV 9496 (S.D.N.Y.),94 CV 477 (E.D.N.Y.),No. 92 CV 7821 (S.D.N.Y.),94 CV 7731 (S.D.N.Y.),92 CV 9471 (S.D.N.Y.),94 CV 3349 (E.D.N.Y.),94 CV 1145 (E.D.N.Y.),94 CV 3293 (E.D.N.Y.),96 BI 1 (S.D.N.Y.),93 CV 159 (E.D.N.Y.),93 CV 5697 (E.D.N.Y.),92 CV 7821 (S.D.N.Y.)
• Citation: 942 F.Supp. 958
• Parties: In re BREAST IMPLANT CASES.
• Court: U.S. District Court — Southern District of New York

942 F.Supp. 958

In re BREAST IMPLANT CASES.

Nos. 92 CV 7821 (S.D.N.Y.), 92 CV 9471 (S.D.N.Y.), 92 CV 9496 (S.D.N.Y.), 94 CV 7731 (S.D.N.Y.), 96 BI 1 (S.D.N.Y.), 93 CV 159 (E.D.N.Y.), 93 CV 5697 (E.D.N.Y.), 94 CV 477 (E.D.N.Y.), 94 CV 1145 (E.D.N.Y.), 94 CV 3293 (E.D.N.Y.), 94 CV 3349 (E.D.N.Y.), 94 CV 3336 (E.D.N.Y.), 94 CV 3358 (E.D.N.Y.) and 96 BI 1 (E.D.N.Y.).

United States District Court, E. and S.D. New York.

October 23, 1996.

Perry Weitz, Robert Gordon, Denise Dunleavy, Mike Williams, Weitz & Luxenberg, New York City, for Plaintiffs.

Mary A. Wells, Wells, Anderson & Race, L.L.C., Denver, CO, William B. Griffin, Brobeck, Phleger & Harrison L.L.P., New York City, George H. Link, Debra E. Pole, Brobeck, Phleger & Harrison L.L.P., Los Angeles, CA, for Baxter. Tamar P. Halpern, Phillips, Lytle, Hitchcock, Blaine & Huber, Buffalo, New York, Joseph M. Price, Faegre & Benson, Minneapolis, MN, Jane Fugate Thorpe, Pursley, Howell, Lowery & Meeks, Atlanta, GA, David P. Herrick, Jenkens & Gilchrist, Dallas, TX, Arvin Maskin, Weil, Gotshal & Manges, New York City for 3M.

Eric M. Kraus, James T. Conlon, Sedgwick, Detert Moran & Arnold, New York City, Nathan Schactman, Jack Flaherty, McCarter & English, Newark, NJ, for Bristol Mayer.

Before BAER, District Judge, and WEINSTEIN, Senior District Judge:

AMENDED PRELIMINARY MEMORANDUM

I. Introduction

Typical of the breast implant cases pending in the two courts is the one briefly described below. Defendants have moved for summary judgment and for various in limine rulings, including exclusion of testimony of plaintiffs' primary experts. Defendants have also opposed the courts' suggestion that there be severance of issues. The motion for summary judgment must be denied with leave to renew. Severance must be granted.

Plaintiffs Anna and Joseph Nyitray sue defendants Baxter Healthcare Corporation and Baxter International Inc. alleging severe and permanent injuries resulting from exposure to silicone in Ms. Nyitray's silicone gel breast implants. 93 CV 159 (E.D.N.Y.). The complaint, as in related cases, alleges numerous causes of action, including negligence, fraud and misrepresentation, strict liability, breach of express and implied warranties, violation of various consumer protection statutes, and loss of consortium. They claim a variety of silicone-related illnesses, some of which can be denominated as "local injuries" and others as "systemic diseases." Plaintiffs' local injuries allegedly include pain and suffering arising from capsular contracture, rupture, leakage, migration, granulomas, infection and temporary or permanent disfigurement. Plaintiffs' claimed systemic illnesses include autoimmune and connective tissue disorders. Both sets of claims require intricate expert scientific testimony.

II. Procedural History

Justice Joan Lobis, New York Supreme Court, New York County, was assigned to supervise preparation for all breast implant cases filed in New York State Supreme Court; Judge Harold Baer, Jr., United States District Court for the Southern District of New York, was assigned all cases pending in the Southern District; and Senior Judge Jack B. Weinstein, United States District Court for the Eastern District of New York, was assigned all cases pending in the Eastern District. The three judges met together with federal magistrate judges assigned to these cases in chambers and en banc in the New York Supreme Court courthouse and in the Southern and Eastern District courthouses to consider expediting disposition.

The parties have estimated that thousands of breast implant cases may shortly be transferred to New York state and federal courts. To avoid a serious judicial emergency the three judges and two magistrate judges agreed with all counsel that they would need to carry forward expeditiously the extraordinarily helpful work of Chief Judge Sam C. Pointer, Jr., MDL-926 transferee judge, in completing preparation for trial, including coordinating local discovery, simplifying issues and setting cases for trial. See, e.g., Pretrial and Revised Case Management, Order No. 30, MDL-926, March 25, 1996.

An integrated Daubert hearing, Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993), was conducted by and on behalf of all plaintiffs and defense counsel in pending and projected cases. During the extensive evidentiary hearing the three judges and Magistrate Judge Cheryl L. Pollak presided together from the same bench, heard many witnesses, and received in evidence a large collection of documents and scientific papers. In addition, incorporated in the record were transcripts and documents from the Daubert hearings recently held in breast implant cases in other United States District Courts. See, e.g., Hall v. Baxter Healthcare Corp. et. al., 92-182JO-Lead (D.Ore.).

The imaginative procedures and information developed by Judge Robert E. Jones in Oregon proved particularly helpful since they included evaluation by neutral experts appointed by Judge Jones. Chief Judge Sam C. Pointer, Jr. has appointed a national committee of experts pursuant to Rule 706 of the Federal Rules of Evidence. It will probably be some time before this committee's important work will be completed.

We should not rush to judgment where new scientific theories are proposed that lack adequate support or refutation because they are so new. As Thomas S. Kuhn points out in The Structure of Scientific Revolution 52 (2d ed. 1970):

New and unsuspected phenomena are ... repeatedly uncovered by scientific research, and radical new theories have again and again been invented by scientists. History even suggests that the scientific enterprise has developed a uniquely powerful technique for producing surprises of this sort.

While plaintiffs' submissions can hardly be characterized as "revolutionary" in the sense that Kuhn uses this term, it may have the scintilla of plausibility that merits reservation of judgment while evaluation goes forward.

III. Testimony at Daubert Hearing

The plaintiffs submitted evidence suggesting a prima facie case as to at least one defendant that silicone breast implants were inadequately designed and manufactured and that they were sold without appropriate warnings. They also provided proof suggesting a prima case that deficiencies in the product caused ruptures and bleeding of the implants' contents, resulting in pain, inflammation and other local phenomena that required explanation in many cases and caused other damage.

The local disease resulting from the silicone breast implants was defined by one of plaintiffs' experts as follows:

There is a local disease associated with silicone implantation. This local disease includes but is not limited to: capsular contracture, breast pain, chest wall pain, axillary pain, pseudo myocardial infarction syndrome, mastitis, nipple discharge, axillary lymphadenopathy, peri-prosthetic nodules, silicone granulomas, foreign body reaction, myositis of the pectoral muscle, pruritic rashes over the breast and local morphea.

Plaintiffs' exhibit 507. In addition, other local symptoms were caused by mechanical and other problems associated with misshapen breasts and surgical operations to explant and reimplant.

The local diseases are separate and distinct from the claimed systemic diseases. As the plaintiffs' lead clinical expert testified:

The Court: In the asbestos case we treat as separate diseases pleural plaque and asbestosis and mesothelioma. I notice in Exhibit Number 507, item 9, you say there is a, and I emphasize a, "a local disease". Is that a separate disease and entity from the systemic diseases?

The Witness: .... I believe that yes, there are women who develop local disease who do not go on to develop a systemic disease.

The Court: That we understand?

The Witness: To that extent, yes, I believe it is separate. I believe that events going on locally such as cytosine generation may well play a role in the evolution of some but not necessarily all the systemic symptoms. And I further believe that a woman can have the systemic illness without having physical complaints referable to elastomer disease. So to that extent, I think it's more yes than no. We can look at them as separate but related diseases.

The Court: That is similar to what we have in asbestos, isn't it?

The Witness: Yes.

The Court: So to the extent that pleural plaque, for example, would be considered a disease separate from mesothelioma, for our purposes the same could be said or would be said of local diseases and these subsequently developed or concurrently developing or non-developing systemic diseases, is that true?

The Witness: That would be true.

Transcript 953-54.

The evidence of both defendants' and plaintiffs' experts supports the conclusion that the silicone implants at issue do not cause classical recognized diseases such as interstitial pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, or Sjogren's Syndrome. Experts also agreed that the breast implants did not exacerbate classic rheumatology or connective tissue diseases.

It was the position of plaintiffs' experts, controverted by those of defendant, that a new undifferentiated atypical disease associated with exposure to silicone was caused by silicone gel implants. The hundreds of symptoms associated with this undifferentiated disease, the lack of any acceptable agreed upon definition, the inadequacy of any satisfactory supporting epidemiological or animal studies, the lack of a scientifically acceptable showing of medical plausibility, and the questionable nature of the clinical conclusions of treating doctors, all point to a failure of proof in making a prima facie case that silicone implants cause any of the syndromes claimed except for local disease.

IV. Summary Judgement

The deficiency of available proof would normally require a grant of summary judgement to defendants as to all but local symptoms. The national Rule...